Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis
Status: | Enrolling by invitation |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/3/2019 |
Start Date: | February 28, 2017 |
End Date: | May 2022 |
A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis
The primary objective of this study is to evaluate the long-term safety and tolerability of
filgotinib in participants who have completed one of the parent studies of filgotinib in
rheumatoid arthritis (RA).
filgotinib in participants who have completed one of the parent studies of filgotinib in
rheumatoid arthritis (RA).
Key Inclusion Criteria:
- Males or females who may benefit from filgotinib as judged by the investigator AND who
completed a Gilead sponsored filgotinib parent study for RA as outlined below:
- Have completed GS-US-417-0301, GS-US-417-0302 or GS-US-417-0303 on study drug
- OR
- Have completed GS-US-417-0302 on standard of care therapy due to RA non-responder
status
- Females of childbearing potential must have a negative pregnancy test prior to first
dose of study drug in the long term extension (LTE)
- Males and females of childbearing potential who engage in heterosexual intercourse
must agree to protocol-approved methods of contraception
Key Exclusion Criteria:
- Diagnosis of an autoimmune or inflammatory joint disease other than RA, which would
put the participant at risk by participating in the study or would interfere with
study assessments/data interpretation, per judgment of the investigator
- Known hypersensitivity to the study drug or its excipients
- Any medical condition which would put the participant at risk by participating in the
study or would interfere with study assessments/data interpretation, per judgment of
the investigator
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
We found this trial at
74
sites
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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University of Southern California The University of Southern California is one of the world’s leading...
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University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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1200 Broadcasting Road
Wyomissing, Pennsylvania 19610
Wyomissing, Pennsylvania 19610
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